Dark-horse ALS play­er touts open-la­bel sur­vival da­ta af­ter mid-stage flop, with plat­form study due soon

Eight months af­ter miss­ing the pri­ma­ry and sec­ondary end­points on a mid-stage test of its ALS drug, Clene Nanomed­i­cine is back with new da­ta show­ing that its gold nanocrys­tal-based can­di­date de­creased risk of death in an open-la­bel ex­ten­sion study.

Clene is at­tempt­ing to catch up with Amy­lyx, a biotech with a fil­ing un­der FDA re­view and al­ready au­tho­rized in Cana­da, run­ning var­i­ous stud­ies on its own drug for Lou Gehrig’s dis­ease. But mid-stage re­sults last No­vem­ber put a damper on those am­bi­tions.

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